MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE HEMODYNAMICS; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number MERGE HEMODYNAMICS 9.40

Device Problem Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

Merge technical support attempted to remotely access the client pc in question, however a message was received that the "server returns destination host unreachable." merge technical support advised the customer to contact their onsite it department for further troubleshooting.The site reported back to merge healthcare that the client pc regained connection to the network and its replication to the server was current.The corrective measures performed by the site's it staff were not disclosed to merge healthcare.However, the customer explicitly stated that the problem occurred at the site and not with merge hemo.

Event Description

Merge hemodynamics monitors, measures, and records physiological data from a human patient undergoing a cardiac catheterization procedure.The system comprises the patient data module and the merge hemodynamics hemo monitor pc.The two units are connected via a serial interface.All vital parameters and evaluations are registered and calculated in the patient data module.This data is then transmitted to the merge hemodynamics hemo monitor pc via the serial interface.All data can be shown and monitored on the merge hemodynamics hemo monitor pc.On (b)(6) 2016, a customer reported to merge healthcare that the hemo client pc would not connect to the site's server.Information obtained from the customer revealed that the reported problem resulted in a procedure being cancelled and rescheduled for the next day.Other cases were sent to one of the additional labs at the site.With merge hemo not presenting physiological data during treatment, there is a potential for incorrect treatment that could result in harm to the patient.However, there is no indication from the customer that this issue resulted in harm to patients.(b)(4).

• Brand Name: MERGE HEMODYNAMICS
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 6046200
• MDR Text Key: 58020101
• Report Number: 2183926-2016-00772
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE HEMODYNAMICS 9.40
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1